FDA.reportPublic FDA data

NA

Primary DI
07290112850454
Brand
NA
Company
UNIQA DENTAL LTD
Model
USIC-1527
Catalog number
USIC-1527
Device description
Contra-angle driver for implants and cover screw H27 Hex2.42
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290112850454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290112850454072901128504547290112850454

GMDN Terms#

Term, Definition table
TermDefinition
Screwing power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a powered screw insertion function when an appropriate screwdriver bit is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532098872
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290112853578NAUOTR-45551UOTR-455512024-09-04
07290112853592NAUOTR-45552UOTR-455522024-09-04
07290112853615NAUOTR-45553UOTR-455532024-09-04
07290112853639NAUOTR-45554UOTR-455542024-09-04
07290112853653NAUOTR-45555UOTR-455552024-09-04
07290112853677NAUOTR-50401UOTR-504012024-09-04
07290112853684NAUOTR-50551UOTR-505512024-09-04
07290112853691NAUOTR-50701UOTR-507012024-09-04
07290112853707NAUOTR-50402UOTR-504022024-09-04
07290112853714NAUOTR-50552UOTR-505522024-09-04
07290112853721NAUOTR-50702UOTR-507022024-09-04
07290112853738NAUOTR-50403UOTR-504032024-09-04
07290112853745NAUOTR-50553UOTR-505532024-09-04
07290112853752NAUOTR-50703UOTR-507032024-09-04
07290112853769NAUOTR-50404UOTR-504042024-09-04
07290112853776NAUOTR-50554UOTR-505542024-09-04
07290112853783NAUOTR-50704UOTR-507042024-09-04
07290112853790NAUOTR-50405UOTR-504052024-09-04
07290112853806NAUOTR-50555UOTR-505552024-09-04
07290112853813NAUOTR-50705UOTR-507052024-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03